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Lifestyle Intervention Feasibility for Arrhythmia and Symptoms With Intermittent Fasting (LIFE AS IF) (LIFE AS IF)

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ClinicalTrials.gov Identifier: NCT04090840
Recruitment Status : Recruiting
First Posted : September 16, 2019
Last Update Posted : September 20, 2019
Sponsor:
Information provided by (Responsible Party):
University of Chicago

Study Description
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Brief Summary:

BACKGROUND AND RATIONALE

Two out of three Americans are overweight and obesity is associated with hypertension, sleep apnea, atrial fibrillation. Metabolic syndrome with centripetal obesity is also a precursor to insulin resistance and the development of Type II diabetes mellitus. While multiple strategies for weight reduction are often recommended in physician visits, calculating calories and energy expenditure is often inconvenient and does not promote compliance. Intermittent fasting, or time-restricted eating, is a methods to limit caloric intake by fasting for 16 hours to promote ketosis and suppress insulin secretion. Weight loss and reduction in body fat has been observed with brief periods of intervention as time-restricted eating results in reduction in overall caloric intake. Prospective feasibility studies and randomized comparative trials with intermittent fasting are lacking.

The investigators recommend caloric restriction in all of our patients that suffer from arrhythmias and BMI >30. However, they have not systematically measured compliance and the efficacy of lifestyle interventions. Lifestyle counseling and weight loss has been shown to decrease the progression and burden of symptomatic atrial fibrillation. Intermittent fasting can result in consistent reductions in body fat and weight without specific lifestyle counseling. The aim of the present observation cohort study is to assess the feasibility of recommending intermittent fasting in an arrhythmia clinic with regard to compliance and efficacy.

The investigators hypothesize that compliance and adherence to a 16/8 intermittent fasting regimen will be >25% and result in weight loss, compared to the 6 month trend prior to the intervention. This pilot study will serve as the basis to power the first randomized trial comparing intermittent fasting with other types of dietary counseling for arrhythmia outcomes.

OBJECTIVES

To prospectively assess compliance to prescribed intermittent fasting, measured by adherence and change in weight at 6 months.


Condition or disease Intervention/treatment Phase
Obesity Morbid Obesity Diabetes Mellitus, Type 2 Atrial Fibrillation Behavioral: Intermittent Fasting Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Prospective observation study of lifestyle intervention with intermittent fasting (time-restricted eating) of 16 hours every day.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Lifestyle Intervention Feasibility for Arrhythmia and Symptoms With Intermittent Fasting (LIFE AS IF)
Actual Study Start Date : August 1, 2019
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Intermittent Fasting
Patients will follow intermittent fasting for 16 hours with time restricted eating during an 8 hour window. The subjects are also advised to minimize sugar intake to <15g per serving.
 Behavioral: Intermittent Fasting
Time restricted eating for 8 hours per day, with 16 hour fast. During the daily fast, patients are encouraged to drink water, black coffee, or green tea without sugar, cream, milk, or sweeteners.


Outcome Measures
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Primary Outcome Measures :
  1. Weight loss [ Time Frame: 6 months ]
    Patients will be weighed weekly for the first month and than have weight checks in clinic monthly


Secondary Outcome Measures :
  1. Body Mass Index [ Time Frame: Monthly until 6 months ]
    calculated from height and weight measured in clinic

  2. Waist Circumference [ Time Frame: Monthly until 6 months ]
    measured by research specialist at umbilicus

  3. Blood Pressure [ Time Frame: Monthly until 6 months ]
    measured in clinic by nursing staff

  4. Quality of Life Assessment [ Time Frame: 6 months ]
    SF36 Questionnaire to be filled out by patient

  5. Hemoglobin a1c [ Time Frame: 6 months ]
    Blood test in patients with diabetes mellitus


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥18
  • BMI≥ 30
  • Ongoing evaluation and management of cardiac arrhythmias

Exclusion Criteria:

  • Pregnant or nursing
  • Eating disorder or history of eating disorders (self-report)
  • Diabetic mellitus type 1 or insulin requiring type 2 diabetes
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04090840


Contacts
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Contact: Tiffany Hart 7737020535 thart@medicine.bsd.uchicago.edu

Locations
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United States, Illinois
The University of Chicago Recruiting
Chicago, Illinois, United States, 60637
Contact: Tiffany Hart    773-702-0535    thart@medicine.bsd.uchicago.edu   
Contact: Roderick Tung, MD    773-834-0455    rtung1@medicine.bsd.uchicago.edu   
Sponsors and Collaborators
University of Chicago
Investigators
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Principal Investigator: Roderick Tung, MD University of Chicago
More Information
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Publications:

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Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT04090840    
Other Study ID Numbers: IRB19-0879
First Posted: September 16, 2019    Key Record Dates
Last Update Posted: September 20, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Chicago:
obesity
fasting
diet
Additional relevant MeSH terms:
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Atrial Fibrillation
Obesity
Diabetes Mellitus, Type 2
Obesity, Morbid
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
 Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases